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NCT07343986 · ClinicalTrials.gov registry record · Phase 1
Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma
A Phase 1 study of Glioblastoma (GBM), sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07343986: Recruiting Phase 1 study of Glioblastoma (GBM), sponsored by University of Virginia.
NCT07343986 is a Phase 1 study of Glioblastoma (GBM) that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 12 participants, below the 85-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07343986, a Phase 1 study of Glioblastoma (GBM), is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 1 study for patients with newly diagnosed MGMT unmethylated IDH wild-type glioblastoma utilizing autologous activated T-cells armed with bispecific antibody (EGFR-BATs) that recognize the tumor. The investigators hypothesized that the combination of infusions of EGFR BATs and low-intensity focused ultrasound would induce blood-brain barrier opening and increase the permeability of the adoptive immunotherapy. The investigators will radiolabel the EGFR BATs with 89Zr-oxine for subsequent PET imaging to determine the trafficking and uptake of this approach. There is a concern that several infusions of EGFR BATs before BBB opening could change the immune tumor microenvironment that would not allow a permissive BBB after LIFU. Therefore, Arm A will have two LIFU with BBB opening after the 4th and the 8th infusion, and Arm B will have three LIFU with BBB opening after the 1st, 4th, and 8th infusions. This study will determine the safety and feasibility of the combination of low-intensity focused ultrasound (LIFU) with microbubbles BBB opening and EGFR BATs and the access of the adoptive cell immunotherapy to the tumor microenvironment to inform future studies.
Primary Outcome
The safety will be evaluated by determining the number of participants who experience Grade ≥3 DLTs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during EGFR BAT and LIFU BBB opening after RT/TMZ. The scale displays Grades 1 through 5 and refers to the severity of the AE. A higher grade (e.g., 5) represents a worse outcome.
Conditions Studied
Interventions
- DEVICE Low-Intensity Focused Ultrasound
- DRUG anti-EGFR bispecific-armed T cells
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-01 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT07343986 shows while recruiting
NCT07343986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 85-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Glioblastoma (GBM) appearing as the primary indexed condition, and to 2 interventions - of which Low-Intensity Focused Ultrasound is the first listed.
NCT07343986 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT07343986 about?
NCT07343986 is a clinical study titled "Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma". This is a phase 1 study for patients with newly diagnosed MGMT unmethylated IDH wild-type glioblastoma utilizing autologous activated T-cells armed with bispecific antibody (EGFR-BATs) that recognize the tumor. The investigators hypothesized that the combination of infusions of EGFR BATs and low-int...
What is the current status of trial NCT07343986?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-01. Estimated completion is 2028-12.
What conditions does trial NCT07343986 study?
This clinical trial studies the following conditions: Glioblastoma (GBM).
What interventions are being tested in trial NCT07343986?
The interventions under investigation include: Low-Intensity Focused Ultrasound (DEVICE), anti-EGFR bispecific-armed T cells (DRUG).
Who is sponsoring clinical trial NCT07343986?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07343986 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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